Kornimate/medical-research-clean huggingface dataset:
phase ii study evaluating exemestane alone or in combination with pazopanib in postmenopausal women with hormone receptor positive breast cancer

Conditions: Hormone-receptor Positive Breast Cancer

Summary: this study is being conducted to compare the efficacy and safety of exemestane alone or in combination with pazopanib in postmenopausal women who have hormone receptor positive breast cancer and have failed therapy with tamoxifen, anastrazole or letrozole.


Eligibility criteria:
inclusion criteria: * subjects must have measurable disease or must be evaluable for disease progression * age \>/= 18 years. * postmenopausal women * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. * histologically or cytologically confirmed er and/or pgr positive carcinoma of the breast with unresectable, locally advanced and/or metastatic disease * subjects must have received prior hormonal therapy for the treatment of breast cancer (anastrozole, letrozole, or tamoxifen) * adequate hematologic, hepatic, and renal function exclusion criteria: * prior use of exemestane or pazopanib * premenopausal women * any ongoing toxicity from prior anti-cancer therapy that is \>grade 1 and/or that is progressing in severity. * prior therapy with a vegf inhibitor. * use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product. * evidence of recurrence or active disease from prior malignancy. * clinically significant gastrointestinal abnormalities that may increase the risk for gi bleeding or affect the absorption of the investigational product(s). * presence of uncontrolled infection. * history of any major cardiovascular conditions within the past 6 months: * poorly controlled hypertension * history of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (dvt) within the past 6 months. * prior major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer * evidence of active bleeding or bleeding tendency.

Keywords: breast cancer advanced metastatic pazopanib gw786034 exemestane efficacy tolerability health-related quality of life
serum concentration of tranexamic acid after topical administration in massive weight loss skin reducing surgery

Conditions: Surgical Wound; Bleeding

Summary: tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces bleeding. it is routinely given intravenously in many surgical situations where there is a risk of major bleeding. concerns regarding possible adverse effects from intravenous use prevents a more widespread use, even in smaller surgeries. topical application - using the drug directly on the wound surface- may give a higher concentration at the site of bleeding but a lower concentration in the rest of the body, and hence a lower risk of adverse effects. here it will be investigated to what extent a defined dose of the drug is absorbed systemically - into the blood stream - when it is applied topically. this will then be compared to the concentration in the blood stream when administered intravenously. blood samples will be obtained at defined time intervals after administration from patients receiving topical and patients receiving intravenous administration of the same single dose of tranexamic acid. will less of the drug enter the blood stream if it is applied directly to the wound?


Eligibility criteria:
inclusion criteria: * planned for major skin reduction surgery (abdominoplasty/panniculectomy) after massive weight loss, or * planned for orthopaedic hip replacement surgery exclusion criteria: * pregnancy * breastfeeding * known allergy to tranexamic acid/cyklokapron® * ongoing or former thromboembolic event * known kidney failure, as defined by estimated glomerular filtration rate (egfr)\<60 ml/min

Keywords: hemostasis, surgical tranexamic acid antifibrinolytic agents administration, cutaneous administration, intravenous administration, topical
the effect of high and low sodium intake on urinary aquaporin-2 in essential hypertension

Conditions: Essential Hypertension and Healthy Controls

Summary: the aim of the study is to test the following hypotheses: * that the function and/or regulation of aqp2 and/or enac in the principal cells is abnormal in essential hypertension. * if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.


Eligibility criteria:
inclusion criteria: * caucasian men and women * age 18-65 years * arterial hypertension * body mass index between 18.5 and 30 kg/m2 exclusion criteria: * secondary hypertension * isolated systolic hypertension * history or clinical signs of ami, atrial fibrillation, disease of the heart valves, or chronic heart failure. * malignant disease * prior apoplexy * alcohol or drug abuse * drug use except antihypertensives and oral contraceptives * abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (\> 200 micromol/l), b-hemoglobin, p-sodium, p- potassium, p-albumine, p-bilirubin, p-alanine aminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose. * abnormal screening of the urine regarding: blood, albumine and glucose. * abnormal electrocardiogram * blood donation within one month of the first examination day * unwillingness to participate

Keywords: urinary aquaporin-2 enac fractional sodium excretion high/low sodium diet
use of a portion control food tool to induce weight loss in obese type 2 diabetics.

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: the purpose of this study was to determine whether a food portion control tool would be effective to result in weight loss in a group of overweight type 2 diabetics. we hypothesized that this tool would be effective to induce weight loss in these patients. we also hypothesized that diabetic control would be improved in patients using these plates.

the prevalence of obesity is increasing worldwide. portion size is known to be an important determinant of energy intake. however, to our knowledge, no clinical trials have previously been conducted which examine the efficacy of a food portion control tool to control caloric intake and thereby induce weight loss. most cases of type 2 diabetes can be attributed directly to obesity. dietary caloric restriction has been shown to improve glycemic control by virtue of weight loss, with an additional benefit independent of weight loss. comparison: daily use of a food portion control tool plus usual care at a diabetes care center, compared to usual care alone.

Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosis of type 2 diabetes mellitus * body mass index of 30 or greater * a member of the diabetes education center in calgary, ab, canada, for at least 6 months prior to study enrollment exclusion criteria: * taking a weight loss medication (sibutramine or orlistat) * weight loss \>10 lbs in 2 months preceding study enrolment * consumption of dinner at restaurants more than twice weekly * current diagnosis of cancer * psychiatric illness under care of a psychiatrist * surgery in the 3 months prior to the study, or expected during the study period * history of bulimia or anorexia nervosa

Keywords: obesity type 2 diabetes mellitus portion control
influence of antiviral treatment to the long-term prognosis of patients with chronic hbv infection

Conditions: Hepatitis B, Chronic

Summary: influence of antiviral treatment to the long term prognosis of patients with chronic hbv infection. the aim of antiviral treatment for hbv is to reduce the long term severe complications. in this study, the investigators divided patients with chronic hbv infection into two groups, which start early antiviral treatment and conventional antiviral treatment respectively. all the patients will be followed for ten years. from this study, the investigators want to find out the optimal time for patients with chronic hbv infection to start antiviral treatment.


Eligibility criteria:
inclusion criteria: * hbsag positive for more than 6 months. * hbeag positive. * hbv dna over 10e5 copies/ml. exclusion criteria: * previous antiviral treatment for hbv. * co infection of hiv, hcv, hev, hav, or hav. * evidence of hepatic carcinoma. * evidence of autoimmune disease. * evidence of thyroid disease. * history of mental sickness.

Keywords: chronic hepatitis b antiviral treatment long term prognosis
prediabetes, prehypertension and vitamin d supplementation - a practice based clinical intervention pilot study

Conditions: Prediabetes; Prehypertension

Summary: this randomized, double-blind, placebo-controlled, multi-site study is to reverse modest elevations of fasting blood sugar (prediabetes) and resting blood pressure(prehypertension) or both co existing prediabetes and prehypertension by increasing blood levels of vitamin d. this may reduce the chances of developing diabetes or high blood pressure or both later in life.

study visits will measure temperature, fasting glucose, resting blood pressure, respiratory rate, height, weight and waist circumference. a brief medical history will be taken, followed by an abbreviated physical exam. a blood test to check your vitamin d level and routine chemistry including a complete lipid profile, liver and kidney function will be completed. based on your fasting glucose and/or resting blood pressure you will be in one of the three arms: prediabetes (arm 1), prehypertension (arm 2) or co-existing prediabetes and prehypertension (arm 3). after determining the arm of the study you are in, you will be randomly assigned to receive either a placebo or vitamin d supplementation. if you are in the first arm with prediabetes (fasting glucose 100-125 mg/dl), the primary outcome measure will change in fasting glucose at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. if you are in the second arm with prehypertension (resting blood pressure 120-139/80-89 mm hg), the primary outcome measure will change in resting blood pressure at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. if you are in third arm with prediabetes and prehypertension, both these measures will be taken at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. a repeat blood test to check vitamin d levels will be done at 8 and 16 weeks (and periodically as necessary) during the study. other measures will be taken as are routine in your doctor's office.

Eligibility criteria:
inclusion criteria: * healthy male or female 18 years or older presenting to the america family practice, physicians care center offices or egan wellness clinic/anti-aging \& skin care spa. * agreeable to treatment with placebo or vitamin d 1000iu twice a day with food. exclusion criteria: * women who are pregnant or nursing * anyone with chronic medical conditions requiring regular intake of any prescription medications.

Keywords: vitamin d prediabetes prehypertension
does preoperative pain medication management influence surgical outcomes in spinal fusion

Conditions: Opioid Use; Spine Fusion

Summary: in light of the current opioid epidemic, there is an urgent need to address chronic opioid use prior to surgery before it is exacerbated by postoperative surgical pain. our central hypothesis is that patients who taper their opioid use prior to surgery will have reduced postoperative opioid and pain medication usage, less postoperative pain, and improved patient reported outcomes relative to patients that do not taper prior to surgery. our specific aims include: 1. determine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative opioid and pain medication use. 2. examine whether reducing patients' preoperative opioid usage through a structured tapering regimen reduces postoperative pain. 3. determine whether reducing patients' preoperative opioid usage through a structured tapering regimen improves patient reported outcomes.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * indicated for lumbar, lumbosacral, or thoracolumbar spinal fusion surgery in the departments of orthopedic surgery and neurosurgery * daily opioid use for at least 4 weeks prior to the preoperative planning appointment exclusion criteria: * suboxone (buprenorphine) use * unable to complete patient reported outcome measures (proms)
the effectiveness of laser acupuncture and standard medication therapy on mandibular post-odontectomy patients

Conditions: Laser Acupuncture; Impacted Third Molar Tooth

Summary: acute toothache is a problem that often occurs in the oral cavity. toothache can be caused by an impacted tooth, in which the tooth cannot or will not erupt into its normal position. the american association of oral and maxillofacial surgeons (aaomfs) states that 9 out of 10 people have at least one impacted tooth, and impacted mandibular third molars have the greatest prevalence. laser acupuncture is an acupuncture modality that has the benefit of reducing pain after third molar extraction. the goal of this randomized controlled trial is to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. the main objective of this study is to analyze the combination of laser acupuncture and medication significantly improving the patient's pain intensity, interincisal distance and post-odontectomy swelling compared to the combination group of sham laser acupuncture and medication.

this is a clinical trial study to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. the required sample was 57 mandibular third molars in male/female subjects post-odontectomy and randomized into 2 groups: (1) combination of laser acupuncture with standard medication and (2) combination of sham laser acupuncture with standard medication. the subjects will receive two times treatment, on day-1 (baseline) and day-3 after odontectomy. the outcome will be assessed on day-1 (baseline), day-3 and day-7 post-odontectomy. patients and outcome assessors will be blinded to the group allocation.

Eligibility criteria:
inclusion criteria: * male or female subject * age 18 - 40 years * classification of pell and gregory class i, ii and positions a, b, c * willing to participate in this research and sign informed consent exclusion criteria: * pregnancy * have a history of using corticosteroid drugs in the last 3 months * have a history of medication with analgesics at least 24 hours before surgery * have an unstable systemic disease (such as uncontrolled hypertension and diabetes etc.) * the patient has a medical emergency / hemodynamically unstable (such as having a hypertensive crisis) * wounds or skin diseases at the location of the acupuncture point irradiation * patients with a history of epilepsy * high fever (\> 38oc).
l-carnosine prophylactic effect on oxaliplatin induced peripheral neuropathy in git cancer patients

Conditions: Peripheral Neuropathy; Cancer

Summary: this study evaluates the prophylactic effect of exogenous l-carnosine in oxaliplatin induced peripheral neuropathy, thus half of the patients will receive l-carnosine with oxaliplatin and the other half will not receive l-carnosine with their chemotherapy (oxaliplatin),and then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .

oxaliplatin causes peripheral neuropathy , l-carnosine is supposed to prevent this side effect possibly by reducing oxidative stress and enhancing the growth of nerves.this study is intended to clarify the effect and mechanism of action of l-carnosine in preventing oxaliplatin induced peripheral neuropathy in cancer patients. blood samples will be collected from the patients before starting the chemotherapy and at the end of treatment duration (3 months) and then oxidative stress markers will be measured in these samples

Eligibility criteria:
inclusion criteria: patients are eligible to be enrolled in this study, if they meet the following criteria 1. elderly males and females with age (˃18 and ˂60). 2. cancer patients treated with oxaliplatin for the first time (dose 85- 135mg/m2) administered every two to three weeks for 3 months. exclusion criteria: excluded from this study are the patients with the following criteria: * suffering from diabetes mellitus. * suffering from peripheral neuropathy as a result of any other disease or drug. * suffering from severe renal impairment (crcl ˂ 30 ml/min). * suffering from epilepsy. * taking vitamin b. * who previously took oxaliplatin or any other chemotherapeutic agent that causes peripheral neuropathy. * taking antidepressants or maoi's. * taking nsaids, paracetamol, opiates or any other analgesics or pain killers. * pregnant or lactating patients.

Keywords: oxaliplatin, peripheral neuropathy, l-carnosine
intraperitoneal chemotherapy in recurrent ovarian cancer

Conditions: Intravenous Chemotherapy Versus Intraperitoneal Chemotherapy in Recurrent Ovarian Cancer

Summary: this study aims to compare intravenous chemotherapy versus intraperitoneal chemotherapy in patients with recurrent ovarian cancer.


Eligibility criteria:
inclusion criteria: * women who had recurrent ovarian cancer and was treated with either intravenous or intraperitoneal platinum based chemotherapy exclusion criteria: * women who did not complete the designated treatment course (exception to those who had to quit due to progressive disease or death of any cause)
comparison of two position for ultrasound guided lumbar plexus and sciatic nerve block

Conditions: Lower Limb Surgery

Summary: in the present study, the investigators will test the effect of two position on posterior lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.

the posterior lumbar plexus block approach was described approximately 30 years ago, using surface anatomical landmarks and a loss-of-resistance technique, but over the years it was almost abandoned for its low successful rate, the huge numbers of adverse effects and its difficulties to be performed. the introduction of the nerve stimulator and ultrasound guided technique in recent years increased the success rate in various peripheral nerve blocks and decreased adverse effects. ultrasound guided lpb as well as sciatic nerve block technique in a small patient population resulting in a encouraging result, but published clinical data on optimal patient position for ultrasound-guided lpb are limited. we designed this prospective randomized study to compare the success rate, time of performance and complications of ultrasound guided posterior lumbar plexus block as well as subgluteal or sub-greater trochanter sciatic nerve block under lateral decubitus position v.s. prone position.

Eligibility criteria:
inclusion criteria: * 18 to 75 years old * elective unilateral lower limb surgery * asa physical status asa i-iii exclusion criteria: * age \ 75 year old * asa physical status \>asa iii * abnormal blood coagulation * infection near puncture place * nerve injury * bilateral lower limb surgery * patients with lumbar vertebral trauma * inability to be properly positioned * chronic narcotic therapy or illicit drug use

Keywords: lumbar plexus block sciatic nerve block position ultrasound guidance elective lower limb surgery
combined on-demand sildenafil citrate and tramadol hydrochloride for treatment of premature ejaculation

Conditions: Premature Ejaculation

Summary: premature ejaculation (pe) is a common sexual dysfunction that has a negative impact on both sex partners. several lines of treatment have been proposed for the treatment of pe i.e. psychological, behavioral, physiotherapeutic, and pharmacological therapies.several treatment options have been proposed for treatment of pe including tramadol hcl and pde5 inhibitors tramadol hcl is thought to exert its therapeutic action in pe patients

it's clear that pe poses much burden not only on the patient sexual life but also on all aspects of the life of both the patient and his partner. several treatment options have been proposed for treatment of pe including tramadol hcl and pde5 inhibitors . tramadol hcl is thought to exert its therapeutic action in pe patients through one or more of the following mechanisms: weak µ-opioid effect, 5-ht2 receptor antagonist effect, n-methyl-d-aspartate receptor antagonist effect, serotonin and norepinephrine reuptake inhibitory effect , and acetylcholine receptor antagonist effect . on the other hand, pde5 inhibitors are thought to play a therapeutic role in treating pe though the following mechanisms: peripheral delay of ejaculation through modulation of contractions of the vas deferens, seminal vesicles, prostate and urethra, increasing the duration of erection , central decrease of the sympathetic output via modulation of no activity in the medial pre-optic area , peripheral analgesic effect, peripheral analgesic effect, increasing patient confidence, and improving the perception of ejaculation control and sexual satisfaction .

Eligibility criteria:
inclusion criteria: * no previous medical treatment for pe * history of premature ejaculation (pe), primary or secondary, and a maximum ielt of 2 minutes prior to treatment. exclusion criteria: * drug noncompliance, positive history of diabetes mellitus, psychological problems, neurological disorders, erectile dysfunction, chronic illnesses, interpersonal troubles with the spouse, as well as long term medications that could affect the patient condition.
evaluation of the dental educational environment using the dreem tool

Conditions: Educational Problems

Summary: this cross-sectional study aims to evaluate the dental educational environment in upper egypt using the dundee ready education environment measure (dreem) questionnaire.

this cross-sectional study aims to evaluate the dental educational environment in upper egypt using the dundee ready education environment measure (dreem) questionnaire. the questionnaire will be sent to students in faculty of dentistry, beni-suef university to assess their perception of the educational environment.

Eligibility criteria:
inclusion criteria: * students registered in the faculty of dentistry, beni-suef university exclusion criteria: - students registered in any dental school other than the faculty of dentistry, beni-suef university.

Keywords: educational environment dreem tool